Predictors of Intravenous Ketamine Response in TRD (NCT05625555) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Predictors of Intravenous Ketamine Response in TRD
Canada40 participantsStarted 2024-01-19
Plain-language summary
For patients with treatment-resistant depression (TRD), a single low dose of intravenous (IV) ketamine can help relieve symptoms as quickly as 24 hours later.
The main problem with IV ketamine for TRD is that the effect is short-lived, lasting only days to 1 or 2 weeks. Furthermore, IV ketamine is a resource-intensive treatment, and the safety of long-term, repeated use for depression is unknown. To provide this treatment in a safe and cost-effective way, Investigators must allocate it efficiently to those patients who have the greatest need and probability of benefit. Therefore, this project aims to find clinical features (signs, symptoms, and parts of a patient's history) that will help predict which patients are most likely to respond to a single dose of IV ketamine for TRD. This will help guide patient selection and triaging.
Investigators will recruit 40 participants with TRD, and randomize them to one of two conditions (ketamine followed by an active placebo 3-weeks later, or vice versa). With clinical data collected through detailed interviews, questionnaires, actigraphy, speech sampling, electroencephalography (EEG), and computerized tasks, this study design will let us evaluate how well such factors predict (A) rapid response at 24-hours, and (B) sustained response at 7 and 14 days.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able to fluently read in English with or without optical correction
* Ability to understand and comply with the study requirements
* This is determined by the investigators
* Provision of written informed consent
* Documented diagnosis of MDD or bipolar disorder meeting DSM-5 criteria (as confirmed by the Diagnostic Assessment Research Tool), currently in a single or recurrent episode without psychotic features
* Failure of at least two antidepressant medications from different pharmacological classes, as well as at least one augmentation agent, each of which must have been given at adequate doses for at least 6 weeks (recorded using the Antidepressant Treatment History Form - Short Form).
* Augmentation strategies include those listed in the 2016 Canadian Network for Mood and Anxiety Treatments (CANMAT) depression guidelines, including a 12-week course of cognitive behavioural therapy or interpersonal therapy.
* MADRS score of ≥25 at initial assessment and Day -1.
* For premenopausal females who are currently sexually active with male partners:
* Negative serum beta-HCG test at enrolment
* AND commitment to using an appropriate birth control method of their choice throughout the duration of the study, including
* Intrauterine device
* Oral contraceptive
* Long-term injectable contraceptive
* Double-barrier method
* Implant
* Dermal contraception
* Tubal ligation
* Abstinence from grapefruit juice consumption on t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically studying IV ketamine for treatment-resistant depression — given my history with antidepressants, does my situation actually fit the profile of 'treatment-resistant,' and would ketamine even be an appropriate option for me to explore?
2The trial is in Phase 3 and measuring changes in a depression rating scale called the MADRSA — what does it mean for safety and effectiveness that it's already in Phase 3, and how confident are researchers at this stage about how well IV ketamine works compared to other options I might have?
3Since this trial covers both Major Depressive Disorder and Bipolar Disorder, and I have one of those diagnoses, does it matter which one I have in terms of how ketamine might affect me differently or carry different risks?
4The trial is active but no longer recruiting new patients — does that mean there's any way I could still access IV ketamine through this study or a related program, or should we be looking at other routes like approved ketamine clinics or a different trial?
5Since this study is trying to identify who responds best to IV ketamine, is there anything in my medical history — like past treatments I've tried or how my depression has presented — that would help predict whether ketamine is likely to work for me or not?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Montgomery Åsberg Depression Rating Scale Score